全自动生化仪日立7600与罗氏c311的比对分析

目的通过日立7600全自动生化仪（日立7600）与罗氏c311全自动生化仪（罗氏c311）检测血清葡萄糖（Glu）项目进行比对分析和偏倚评估，建立分析模式，探讨两台仪器测定结果的可比性。方法参考NCCLSEPl5-A、EP6-A文件，先检测日立7600的精密度与线性范围，结果与厂家声明一致后，再参考NCCLSEP9-A2文件进行比对分析。将40例血清标本按G1u浓度水平分为I组（〈2．80mmol／L，4例），1I组（2．80～6．11mmol／L，16例），III组（6．12～8．30mmol／L，12例），IV组（8．31～14．00mmol／L，4例），V组（14．01～44．20mmol／L，4例）。各组分别在日立7600（比对系统）与罗氏c311（实验系统）上进行检测，计算实验系统与比对系统之间的相对偏差。最后以CLIA’88允许总误差的1／3为标准，判断两台仪器测定结果的可比性。结果日立7600的精密度与线性范围均达到了厂家声明的性能要求。浓度在2．80、7．00、11.10mmol／L3个Glu的医学决定水平处的预期偏倚（Bc）的95％可信区间分别为2．68～2．70mmol／L、6．72～6．80mmol／L、10．59～10．63mmol／L，均满足相应允许浓度范围。结论血清Glu测试在罗氏c311与日立7600的不同检测系统间具有可比性，为进一步全面开展比对分析奠定了基础。

Comparative study of Hitachi 7600 and Roche c311 automatic biochemical analyzers

Objective To investigate the comparability of detection results between Hitachi 7600-020 biochem- ical analyzer （Hitachi 7600） and Roche c3l 1 biochemical analyzer （Roche c311） through detecting serum glucose （Glu） level and estimating bias. Methods Referring to NCCLS EP15-A and EP6-A documents, the experiment of precision and linearity range were firstly run in Hitachi 7600, which was consistent with the manufacturer claim. Then the further comparative analysis was estimated according to EP9-A2 document. According to the Glu level,all 40 ser- um samples were classified into group I （〈2.80 mmol/L,n：4） ,group I] （2.80--6.11 mmol/L,n=16） ,group III （6.12--8.30 mmol/L,n=12）,group IV（8.31--14.00 mmol/L, n=4） , group V （14.01--44.20 mmol/L,n：4）. The Glu concentration of these samples were detected by Hitachi 7600 （comparative system） and Roche c311 （test system）, respectively. The relative deviation between the comparative system and test system was analyzed. Finally 1/ 3 of CLIA＇88 total error as a goal,the comparability between two systems was judged. Results The estimation of the linear range and the precision in Hitachi 7600 were in compliance with the manufacturer claim. The 95 % confidence intervals of the predicted bias（Bc）in the Glu concentration of three medical decision levels were 2.68--2.70 mmol/L, 6.72--6. 80 mmol/L and 10. 59- 10. 63 mmol/L, respectively. All were accepted for the allowable concentration range. Conclusion The comparability of the Glu detection between Hitachi 7600 and Roche c311 built the foundation for the further comparative analysis.